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HIV Infections clinical trials

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NCT ID: NCT01138267 Completed - HIV Infections Clinical Trials

Pharmacogenomic of Atazanavir/Efavirenz (ATV/EFV)

Start date: May 2009
Phase:
Study type: Observational

Objectives: - To evaluate the impact of genetic polymorphism on ARV drug levels - To evaluate the effect of genetic polymorphism/drug levels on long term immunologic and virologic response - To correlate the genetic polymorphism/drug levels on antiretroviral toxicities The long-term objective of this research plan is to characterize impact of pharmacogenomics to HIV drug concentration, toxicities, and response to antiretroviral therapy among HIV-infected adults. A comprehensive understanding of the impact of pharmacogenomics to HIV infection and HIV medication will lead to the development of appropriate intervention such as dose reduction strategies in patients with particular gene(s) correlated with higher drug levels. The dose reduction strategy will decrease long term drug toxicity and cost saving for Thais and Asian Ethnicities.

NCT ID: NCT01138241 Completed - HIV Infection Clinical Trials

Tenofovir Renal Toxicity and Glomerular Filtration Rate (GFR) Validation

Start date: March 2010
Phase:
Study type: Observational

To assess and validate equation eGFR in HIV-infected subjects and -uninfected Thai patients

NCT ID: NCT01138215 Completed - HIV Infections Clinical Trials

The Immunogenicity of Varicella-zoster Virus Vaccine in HIV-infected Children

Start date: June 2009
Phase: Phase 4
Study type: Interventional

To study about the immunogenicity, safety and efficacy of varicella-zoster virus vaccine in HIV-infected children.

NCT ID: NCT01138202 Completed - HIV Infections Clinical Trials

Pharmacokinetics (PK) and Safety of 2 Different Doses of Lopinavir/Ritonavir in in HIV/Tuberculosis (TB) Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy

Start date: November 2010
Phase: Phase 2
Study type: Interventional

To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.

NCT ID: NCT01138072 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.

Start date: June 2010
Phase: Phase 1
Study type: Interventional

This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin, and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2248761. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug.

NCT ID: NCT01137981 Recruiting - HIV Infections Clinical Trials

Antiretroviral Pregnancy Registry (APR)-Risk of Birth Defects

Start date: February 15, 1993
Phase:
Study type: Observational [Patient Registry]

The APR began as the 'Zidovudine in pregnancy Registry' in January 1989 and became the 'Antiretroviral Pregnancy Registry' in January, 1993. The purpose of the APR is to detect any major teratogenic effects involving any of the Registry drugs when administered to pregnant HIV positive women. The Registry is intended to provide an early signal of teratogenicity associated with prenatal use of the antiretroviral drugs. The Registry collects data on prenatal exposures to antiretroviral drugs, potential confounding factors (such as maternal age, disease status during pregnancy), and information about the outcome of the pregnancy. The Registry is managed by INC Research. The scientific conduct and analysis of the Registry data are overseen by an independent Advisory Committee consisting of members from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the academic sector. Registry data are obtained from participating providers who encompass physicians in private practice as well as hospitals and community clinics. The registry is co-sponsored and co-funded by 26 pharmaceutical companies that manufacture drugs used in ART. For an updated version of the registry, please see NCT00404989.

NCT ID: NCT01136759 Completed - HIV Infections Clinical Trials

Tenofovir Gel in Pregnancy and Lactation

Start date: March 2011
Phase: Phase 1
Study type: Interventional

Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.

NCT ID: NCT01134939 Completed - HIV Infections Clinical Trials

Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

Start date: May 2010
Phase: N/A
Study type: Observational

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

NCT ID: NCT01130376 Terminated - HIV-1 Infection Clinical Trials

Novel Interventions in HIV-1 Infection

IMIRC1003
Start date: September 2009
Phase: Phase 1
Study type: Interventional

For several years there has been interest in why some people with HIV-1 progress more slowly to disease and have longer survival without Highly Active Antiretroviral Therapy (HAART) than others. The investigators and others have identified a few HIV positive individuals who can control their viral load for many years without HAART, these rare individuals do not lose their HIV-1-specific cellular immune responses, which are very important for controlling viral load. This group is referred to as long-term non-progressors (LTNP). Unlike LTNP the majority of HIV-1 infected individuals are chronic progressors (CP) who do not make effective HIV-1-specific cellular immune responses, even when on HAART. We propose to use a novel DNA vaccine boosted with immune based therapy (cytokines and hormones) to try to regenerate the missing HIV-1-specific cellular immune responses to make chronically infected HIV-1+ persons more like LTNP. By injecting this novel DNA vaccine and immune based therapy into the people who are already infected with HIV-1, the immune system may be stimulated to mount a greater immune response not only to the vaccines but also to real HIV-1 particles and HIV-1-infected cells.

NCT ID: NCT01129401 Completed - HIV Infections Clinical Trials

Stonewall Treatment Evaluation Project

STEP
Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This treatment outcome evaluation of the Stonewall Project will recruit 150 participants to complete a face-to-face assessment visit at baseline, 3-month follow-up, and 6-month follow-up to examine treatment outcome with respect to HIV risk and substance use.